Wide Hemostasis Clip

ABSTRACT

A device for treating tissue includes a capsule extending longitudinally from a proximal end to a distal end and including a channel extending therethrough, the capsule releasably coupled to a proximal portion of the device and clip jaws, proximal ends of which are slidably received within the channel of the capsule so that the clip jaws are movable between an open configuration and a closed configuration. Clip jaws are configured so that a distance between the distal ends of the clip jaws in an open configuration is between 15 and 18 millimeters. Clip jaws further include barbs extending from a distal portion thereof.

PRIORITY CLAIM

The present disclosure claims priority to U.S. Provisional PatentApplication Ser. No. 62/338,213 filed May 18, 2016; the disclosure ofwhich is incorporated herewith by reference

BACKGROUND

Physicians have become more willing to perform more aggressiveinterventional and therapeutic endoscopic procedures including, forexample, removal of larger lesions (e.g., cancerous masses), tunnelingunder mucosal layers in the gastro-intestinal (GI) tract to treattissues below the mucosa, full thickness removal of tissue, insertingdevices through the GI tract and then penetrating the GI organ to treattissue outside the GI tract, and endoscopic treatment/repair ofpost-surgical issues (e.g., post-surgical leaks, breakdown of surgicalstaple lines, anastomotic leaks). These procedures may increase the riskof perforating or damaging the wall of the GI tract, or may requireclosure of the GI tract wall as part of the procedure. Endoscopicclosure reduces cost and may reduce the trauma and inconvenienceassociated with these procedures. However, conventional tissue closuredevices may be insufficient to close certain larger tissue defects. Forexample, current Resolution clips in the field may be deformed to have ajaw tip to jaw tip distance of approximately 10 to 12 millimeters beforeyielding. A wider jaw opening would allow more tissue to be clipped andtreated for larger tissue issues.

SUMMARY

The present disclosure relates to a device for treating tissue,comprising a capsule extending longitudinally from a proximal end to adistal end and including a channel extending therethrough and clip jaws,proximal ends of which are slidably received within the channel of thecapsule. The clip jaws are movable between an open configuration, inwhich distal ends of the clip jaws extend distally past the distal endof the capsule to be separated from one another, and a closedconfiguration, in which the clip jaws are restrained via an interiorsurface of the capsule so that distal ends of the clip jaws are drawntoward one another. A distance between the distal ends of the clip jawsin the open configuration is between 15 and 20 millimeters and at leastone barb is coupled to a distal portion of the clip jaws.

The present disclosure also relates to a clipping device, comprising aproximal portion and a distal portion releasably coupled to the proximalportion so that the distal portion is deployable therefrom, the distalportion including a capsule extending longitudinally from a proximal endto a distal end and a including a channel extending therethrough, clipjaws extending from proximal ends slidably received within the channelof the capsule so that the clip jaws are movable between an openconfiguration, in which distal ends thereof extend distally past thedistal end of the capsule to be separated from one another, and a closedconfiguration, in which the clip jaws are restrained via an interiorsurface of the capsule so that the distal ends thereof are drawn towardone another, a distance between distal ends of the clip jaws in the openconfiguration being between 15 and 20 millimeters and at least one barbcoupled to a distal portion of the clip jaws, and a control memberextending from a proximal end to a distal end, the distal end coupled toproximal ends of the clip jaws.

The present disclosure also relates to a method for treating targettissue, comprising inserting a distal portion of a clipping device to atarget area within a living body, the distal portion including a capsuleand clip jaws slidably received within the capsule to be movable betweenan open configuration, in which distal ends of the clip jaws areseparated from one another, and a closed configuration, in which distalends of the clip jaws are drawn toward one another, the clip jawsincluding a distance between distal ends of the clip jaws in the openconfiguration between 15 and 20 millimeters and at least one barbcoupled to a distal portion of the clip jaws, positioning the clip jawsin contact with a target tissue, and clipping a target portion of tissueby positioning the target portion of tissue between the clip jaws in theopen configuration and drawing the clip jaw toward the closedconfiguration to grip the target portion of tissue.

BRIEF DESCRIPTION

FIG. 1 shows a longitudinal cross-sectional view of a device accordingto an exemplary embodiment of the present disclosure;

FIG. 2 shows a table of mechanical properties for 17-7 Stainless Steel;

FIG. 3 shows a perspective view of the device of FIG. 1;

FIG. 4 shows a perspective view of a device according to anotherexemplary embodiment of the present disclosure;

FIG. 5 shows a partially transparent longitudinal view of a deviceaccording to another alternate embodiment of the present disclosure;

FIG. 6 shows a cross-sectional view of the clip jaws of the device ofFIG. 5;

FIG. 7 shows a perspective top view of a device according to anotherexemplary embodiment of the present disclosure;

FIG. 8 shows a perspective view of a clip jaw according to anotherexemplary embodiment of the present disclosure;

FIG. 9 shows a longitudinal top view of a device according to anotherexemplary embodiment of the present disclosure;

FIG. 10 shows a longitudinal top view of a device according to anotherexemplary embodiment of the present disclosure;

FIG. 11 shows a longitudinal top view of a device according to anotherexemplary embodiment of the present disclosure.

DETAILED DESCRIPTION

The present disclosure may be further understood with reference to thefollowing description and the appended drawings, wherein like elementsare referred to with the same reference numerals. The present disclosureis directed to an endoscopic clipping device for treating tissueperforations, defects and/or bleeds. Exemplary embodiments of thepresent disclosure describe a hemostatic clip having an increased jawopening and features that allow better traction onto tissue to preventtissue from sliding off jaws while closing. In particular, exemplaryembodiments describe a hemostatic clip with clip jaws formed from amaterial treated to achieve an increased jaw tip to jaw tip distance topermit the clip to grab an increased volume of tissue. Portions of theclip jaws may include barbs or teeth to hold tissue when the clip isclosed. It should be noted that the terms “proximal” and “distal,” asused herein, are intended to refer to toward (proximal) and away from(distal) a user of the device.

As shown in FIG. 1, a device 100 according to an exemplary embodiment ofthe present disclosure comprises a distal portion 102 insertable into aliving body through, for example, a working channel of an endoscope totarget tissue to be treated. The device is sufficiently flexible topermit it to traverse a tortuous path through the body—e.g., passingthrough the working channel of an endoscope inserted through a naturalbody lumen accessed via a natural bodily orifice. The distal portion 102includes first and second clip jaws 104, 106 slidably received within alongitudinal channel 122 of a capsule 108. First and second clip jaws104,106 can be moved between an open configuration, in which the distalends 109, 111 of the clip jaws 104,106 are separated from one another toreceive target tissue therebetween, and a closed configuration, in whichthe distal ends 109, 111 of the clip jaws 104, 106 are moved toward oneanother to grip the target tissue therebetween. The distal portion 102is releasably coupled to a proximal portion 110 of the device 100, whichincludes a handle (not shown) that remains outside the body accessibleto a user as the distal portion 102 is deployed. The clip jaws 104, 106are movable between the open and the closed configurations via a controlmember 112 extending into the capsule 108. A proximal end (not shown) ofthe control member 112 is connected to an actuator on the handle. Inthis embodiment, a distal end 114 of the control member 112 is coupledto proximal ends 116 of the clip jaws 104, 106.

As further shown in FIG. 1, device 100 includes clip jaws 104, 106according to an exemplary embodiment of the present disclosure whichextend from proximal ends 105, 107, respectively, to distal ends 109,111, with a medial curved portion 119. As those skilled in the art willunderstand, jaws 104, 106 of this embodiment are biased toward an opentissue receiving position in which the distal ends 109, 111 areseparated from one another to receive tissue. That is, the jaws 104, 106are formed so that they spring open to the tissue receiving positionwhen they are moved distally out of the constraint of the capsule 108.However, as would be understood by those skilled in the art, the device100 may include a separate member urging the jaws 104, 106 away from oneanother in addition, or as an alternative, to this bias. In an exemplaryembodiment, the clip jaws 104, 106 may have a jaw tip-to-jaw tip openingbetween 15 and 20 millimeters (mm) and, more particularly, between 16and 18 millimeters. The clip jaws 104, 106 according to this embodimentmay also have a length of between 2 and 3 mm greater than current clipjaws. Specifically, the clip jaws may be between 6 and 8 mm and, moreparticularly, a length of 7.5 mm. The clip jaws 104, 106 according tothis embodiment are biased through the formation of the curved medialportion 119 which, is fabricated to include a resting radius ofcurvature (i.e., when unstressed) of approximately 3 mm or less and evenmore particularly has a radius of 2.8 mm or less. The radius of themedial curved portion is selected to maintain a desired spread distancebetween the distal ends 109 and 111 when the clip jaws 104, 106 aremoved distally out of the capsule 108 by a maximum permitted extent. Forexample, in this embodiment, the desired spread distance is between15-18 mm. As will be described in more detail below, the jaws 104, 106are treated to achieve the desired spread distance without causing thematerial of the jaws 104, 106 to yield (i.e., plastically deform). Inthis embodiment, the clip jaws 104, 106 are formed of a material with astrain at yield above 0.7 percent with a yield strength greater than 200kilopounds per square inch (ksi). This higher strain at yield and yieldstrength ensures that the clip jaws 104, 106 return to their originalshape when drawn back into the capsule 108 and that they maintain theirbias then return to the open configuration when extended again distallyfrom the capsule 108. In an exemplary embodiment, the clip jaws 104, 106are formed of 17-7 Stainless Steel, the mechanical properties of whichare well known in the field of art. FIG. 2 provides the typical roomtemperature mechanical properties of 17-7 Stainless Steel after specificstandard heat treatments. As would be understood by those skilled in theart, 17-7 Stainless Steel may be supplied at Condition A or Condition C,the properties of which are provided in FIG. 2. Condition RH-950 isaccomplished by precipitation hardening from Condition C while ConditionCH-900 is accomplished with a single low-temperature heat treatment fromCondition C. In another embodiment, the 17-7 Stainless Steel clip jaws104, 106 may be heat treated to an RH-950 or CH-900 condition as wouldbe understood by those skilled in the art to increase a yield strengthof the clip jaws 104, 106. Heat treating the clip jaws 104,106 mayincrease the strain at yield as high as 1.1 percent or a yield strengthto as high as 260 ksi. Additionally materials such as Cobalt Chrome(Elgiloy) or Nitinol may also be used.

The clip jaws 104, 106 are biased toward the open configuration so that,when the clip jaws 104, 106 are moved distally past a distal end 116 ofthe capsule 108, distal ends 109, 111 of the clip jaws 104,106 separatefrom one another to the open configuration. When the clip jaws 104, 106are drawn proximally into the capsule 108, contact with the capsule 108draws the clip jaws 104, 106 toward one another to the closedconfiguration. They are then held in the closed position by the capsule108. As described above, the clip jaws 104, 106 are moved between theopen and closed configurations via the control member 112 which is movedproximally and distally relative to the capsule 108 via an actuator at ahandle that remains outside the body.

Clip jaws 104, 106 include one or more hooks or barbs 120 attached to aninterior side of a distal portion of clip jaws 104, 106. As shown inFIGS. 3-4, barbs 120 in this embodiment extend substantiallyperpendicularly from the interior face of jaws 104,106 radially inwardtoward the other of the jaws 104, 106. The barbs 120 may likewise extendfrom the interior face of jaws 104,106 at various angles between 20 and90 degrees and, more particularly, 45 degrees relative to thelongitudinal axis L of the jaw 104,106 to allow the barb 120 to grabtissue when the jaw 104,106 is in the open configuration. That is, thebarb 120 may extend outward from the interior face of jaw 104,106 in aplane substantially perpendicular to a plane containing the interiorface of each jaw 104,106 or may extend at an angle and thus in a planethat is not perpendicular to the plane containing the interior face ofthe jaw 104, 106. In an embodiment, the barb 120 is positioned so thatwhen the clip is located adjacent to target tissue and the jaws 104, 106are moved to the closed configuration, barbs 120 on each jaw 104, 106are staggered or offset from one another longitudinally. In analternative embodiment, the barbs 120 may be configured to extend indifferent planes so as to be received by an opposing jaw withoutinterference from the barb 120 of the other jaw. In another embodiment,both of the barbs 120 may be configured to extend in substantially thesame plane so that when jaws 104,106 are in a closed configuration endsof the barbs 120 from opposing jaws 104,106 touch one another. In anexemplary embodiment, as shown in FIG. 3, the barb 120 extends at anangle of 90 degrees relative to the flat jaw.

According to an exemplary method, the distal portion 102 of the device100 may be inserted to a target area within a living body through, forexample, a working channel of an endoscope. The distal portion 102 maybe inserted through the working channel in the closed configuration.Once the distal portion 102 has reached the target area, however, theclip jaws 104, 106 may be moved to the open configuration by moving thecontrol member 112 distally relative to the capsule 108. The clip jaws104, 106 are movable between the open and closed configuration to gripand/or contact tissue in a manner which would achieve the desiredeffect. For example, for clipping, the distal ends 109, 111 of the clipjaws 104, 106 may be positioned about the area of the tissue to beclipped, in the open configuration. The clip jaws 104, 106 may be drawntoward the closed configuration so that the portion of the target areathat is desired to be clipped is gripped between hooks or barbs 120along the distal portion of the clip jaws 104, 106. The hooks or barbs120 may be angled relative to the target tissue so that they do not dragalong the target tissue but grab the tissue that is to be drawn into thecapsule to be clipped. The clip jaws 104, 106 may be moved between theopen and closed configurations until the desired portion of tissue isgripped. Once the portion of the tissue to be clipped has beenpositioned between the clip jaws 104, 106, the clip jaws 104, 106 aremoved toward the closed configuration so that the tissue grabbed by thehooks or barbs 120 is gripped therebetween. The clip jaws 104, 106 arethen moved further proximally into the capsule by the control member 112so that the target tissue is firmly gripped between the clip jaws 104,106 which are held in the closed configuration by the capsule. Thecapsule may then be separated from the proximal portion 110 of thedevice, deploying the clip in the body.

The above-described deployment process is one example of how the distalportion 102 of the device 100 may be deployed. The distal portion 102may be deployed in a variety of different ways, depending on theconfiguration of the clip jaws 104, 106 and the capsule 108, so long asdeployment releases the capsule 108 from a proximal portion 110 of thedevice while also locking the clip jaws 104, 106 in the closedconfiguration.

According to an alternate embodiment, as shown in FIGS. 5-6, a device100′ is substantially similar to the device 100 describe above,comprising distal portion 102′ including clip jaws 104′, 106′ slidablyreceived within a capsule 108′ to be moved between an open configurationand a closed configuration via a control member 112′. Clip jaws 104′,106′ may further include, in an exemplary embodiment, a rib feature 124′extending longitudinally across one or both of the jaws 104′, 106′. Asseen in the cross section of FIG. 6, the rib feature 124′extends alongdistal portions 126′, 128′ of the jaws 104′, 106′. This rib feature 124′which may, for example, be stamped into the jaws 104′, 106′ increases amoment of inertia of the jaws 104′, 106′ in this region 126′, 128′increases the resistance of the jaws 104′,106′ to bending or deformingeven if the length of the jaws 104′, 106′ is increased. This extendedlength permits the device 100′ to capture additional volume of tissue ascompared to clips with shorter jaws. For example, the clip jaws 104′,106′ may have as similar jaw tip-to-jaw tip opening as jaws 104, 106 ofbetween 15 and 20 millimeters (mm) and, more particularly, between 16and 18 millimeters.

The clip jaws 104′, 106′ according to this embodiment may also have alength of between 6 and 8 mm and, more particularly, a length of 7.5 mm,similar to clip jaws 104, 106. With this greater jaw tip-to-jaw tipopening, when the jaws 104′, 106′ are pushed into target tissue, thejaws 104′, 106′ tend to spread further to grasp even more tissue.

In another embodiment, shown in FIG. 7, the rib feature 124′ may bestamped into the jaws 104′, 106′ at the C-Cup region 130′ of the clipjaws 104′, 106′. Including this stamp feature 124′ at the C-Cup region130′ of the clip jaws 104′, 106′ increases a moment of inertia of thejaws 104′, 106′ in this region 130′ so as to increase the resistance ofthe jaws and prevent the C-Cup region 130′ from bending when pulled intothe capsule while gripping captured tissue.

As shown in FIG. 8, a device 200 according to another exemplaryembodiment is substantially similar to the device 100, described above,comprising a pair of clip jaws 204, 206 slidable within a capsule 208between an open configuration and a closed configuration. Rather thanhaving a hook or barb 120 extending from the clip jaws 204, 206,however, the clip jaws 204, 206 have a wing teeth 220 design. Wing teeth220 spread laterally outwards from clip jaws 204, 206 (i.e., away from alongitudinal axis of the device 200) and can be formed as C-shapedgeometries that exist in clips today. Wing teeth 220 can be achieved byadding additional material to a current C-shape or created by cuttinginto a C-shape to create notches having sharper points to engage tissue.The wing teeth 220 are formed on portions of the jaws 204, 206 that donot enter the capsule even when the clip is drawn into the capsule tothe maximum extent. Thus the wing teeth do not interfere with theoperation of the device 200.

As shown in FIG. 9, a device 300 according to an alternate embodiment issubstantially similar to the device 200, described above, comprising apair of clip jaws 304, 306 slidable within a capsule 308 between an openconfiguration and a closed configuration. However, rather than having awing teeth spreading laterally outwards from clip jaws in a C-shapegeometry, the clip jaws 304, 306 have barbs 320 added to the distal endof clip wings 322, 324, allowing for better tissue retention whenclosing the clip jaws 304, 306. Barbs 320 become engaged when thephysician moves the clip jaws 304, 306 to the open configuration andpresses the clip jaws 304, 306 against the target tissue such that theclip jaws 304, 306 are parallel to the tissue surface. Barbs 320 arethen able to capture tissue as the jaws 304, 306 are closed, causing thetissue to “tent” as the clip jaws 304, 306 are further retracted.

As shown in FIG. 10, a device 300′ according to an alternate embodimentis substantially similar to the device 300. Clip jaws 304′, 306′ mayhave barbs 320′ located at a distal end of clip wings 322, 324 as indevice 300. However, in order to improve tissue retention of the distalportion 302′ of the device 300′, barb features 320′ may be overbent suchthat they hook onto tissue as the clip jaws 304′, 306′ are retractedinto the capsule 308′. In another embodiment shown in FIG. 11, in orderto increase traction on the tissue as the clip is retracted into thecapsule, one or more barb features 320′ may be added to the sides ofclip wings 322′, 324′ on clip jaws 304′, 306′ to ensure that tissue iscaught upon retraction. Barb features 320′ may also be placed on onlyone side of the distal portion 302′ of device 300′ to allow for a morecontrolled area of retention.

The devices 200, 300, 300′ may be used in a manner substantially similarto the device 100. In particular, the clip jaws 204, 206, 304, 306,304′, 306′ may be used to clip tissue as described above.

Variations may be made in the structure and methodology of the presentdisclosure, without departing from the spirit and the scope of thedisclosure. Thus, it is intended that the present disclosure cover themodifications and variations of this disclosure that may be contemplatedby a person of skill in the art.

1-15. (canceled)
 16. A device for treating a tissue, comprising: acapsule extending longitudinally from a proximal end to a distal end andincluding a channel extending therethrough; clip jaws, proximal ends ofwhich are slidably received within the channel of the capsule so thatthe clip jaws are movable between an open configuration, in which distalends of the clip jaws extend distally past the distal end of the capsuleto be separated from one another, and a closed configuration, in whichthe clip jaws are restrained via an interior surface of the capsule sothat distal ends of the clips jaws are drawn toward one another, adistance between distal ends of the clip jaws in the open configurationbeing between 15 and 20 millimeters; and at least one barb coupled to adistal portion of the clip jaws.
 17. The device of claim 16, wherein theclip jaws are formed of a material having a yield strength between 200and 260 ksi or an equivalent strain at yield.
 18. The device of claim16, wherein the clip jaws are formed of 17-7 Stainless Steel.
 19. Thedevice of claim 18, wherein the clip jaws are formed of an alternatematerial having a yield at strength equal to that of 17-7 StainlessSteel.
 20. The device of claim 16, wherein the at least one barb extendsfrom the distal portion of the clip jaws at an angle between 20 and 90degrees relative to the longitudinal axis of the clip jaws.
 21. Thedevice of claim 16, wherein the distance between distal ends of the clipjaws in the open configuration is 16 millimeters.
 22. The device ofclaim 16, wherein the distal portion of the clip jaws includes a stampedrib feature.
 23. The device of claim 16, wherein the barbs are formed aswing teeth.
 24. The device of claim, wherein when the clip jaws are inthe closed configuration, barbs on opposing clip jaws are configured tobe staggered.
 25. The device of claim 16, wherein when the clip jaws arein the closed configuration, barbs on opposing clip jaws are configuredto touch.
 26. The device of claim 16, wherein the clip jaws have aradius of curvature of 2.8 mm or less.
 27. A clipping device,comprising: a proximal portion; a distal portion releasably coupled tothe proximal portion so that the distal portion is deployable therefrom,the distal portion including: a capsule extending longitudinally from aproximal end to a distal end and including a channel extendingtherethrough; clip jaws extending from proximal ends slidably receivedwithin the channel of the capsule so that the clip jaws are movablebetween an open configuration, in which distal ends thereof extenddistally past the distal end of the capsule to be separated from oneanother, and a close configuration, in which the clip jaws arerestrained via an interior surface of the capsule so that the distalends thereof are drawn toward one another, a distance between distalends of the clip jaws in the open configuration being between 15 and 18millimeters; and at least one barb coupled to a distal portion of theclip jaws; and a control member extending from a proximal end to adistal end, the distal end coupled to proximal ends of the clip jaws.28. The device of claim 27, wherein the clip jaws are formed of amaterial having a strain at yield equivalent to that of a yield strengthbetween 200 and 260 ksi, including 17-7 Stainless Steel.
 29. The deviceof claim 28, wherein the clip jaws are formed of an alternate materialhaving a strain at yield equal to that of 17-7 Stainless Steel.
 30. Thedevice of claim 27, wherein the at least one barb extends from thedistal portion of the clip jaws at an angle between 20 and 90 degreesrelative to the longitudinal axis of the clip jaws.
 31. A method fortreating target tissue, comprising: inserting a distal portion of aclipping device to a target area within a living body, the distalportion including a capsule and clip jaws slidably received within thecapsule to be movable between an open configuration, in which distalends of the clip jaws are separated from one another, and a closedconfiguration, in which the distal ends of the clip jaws are drawntoward one another, the clip jaws including: a distance between distalends of the clip jaws in the open configuration between 15 and 20millimeters; and at least one barb coupled to a distal portion of theclip jaws; positioning the clip jaws in contact with a target tissue;and clipping a target portion of tissue by positioning the targetportion of tissue between the clip jaws in the open configuration anddrawing the clip jaw toward the closed configuration to grip the targetportion of tissue.
 32. The method of claim 31, wherein positioning theclip jaws in contact with the target tissue includes gripping the targettissue with the at least one barb.
 33. The method of claim 31, whereinthe clip jaws are formed of a material having a strain at yieldequivalent to that of a yield strength between 200 and 260 ksi,including 17-7 Stainless Steel.
 34. The method of claim 33, wherein theclip jaws are formed of an alternate material having a strain at yieldequal to that of 17-7 Stainless Steel.
 35. The method of claim 31,wherein the at least one barb is extends from the proximal portion ofthe clip jaws at an angle between 20 and 90 degrees relative from to thelongitudinal axis of the clip jaws.